Job Responsibilities
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in cross-functional meetings with internal and external parties as required.
Write and implement CAPA Plans and interact with necessary departments and individuals to ensure record is completed by the Original Due Date (ODD); must respond timely to deliver quality and thorough CAPAs
Ensure CAPAs are written in accordance with the companies' requirements.
Implement necessary follow-up verification/milestone checks on Corrective and Preventive Action items, ensure timely follow-up and approval occur throughout term of the CAPA process
Ensure compliance of CAPA program by coordinating with various departments required in execution of CAPA tasks and deliverables, as well as assist in CAPA record extensions.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
Supports maintenance and improvement to quality systems processes, as needed.
Works directly with operating entities and internal clients with assistance from management and/or more senior level investigators to ensure follow-up of quality issues.
Facilitate cross-functional meetings with internal and external parties as required.
Responsible for maintaining tracking tools/databases.
Responsible for sending periodic reminder notifications to leads/coordinators.
May support in conducting, completing, and documenting major and minor deviation investigations related to GxP operations

Requirements
3 – 5 years of experience in biopharmaceutical/biotechnology
Minimum of BA/BS degree in Science or Technical Field; or equivalent practical experience
Knowledge of applicable regulatory standards and Good Manufacturing Practices
Must have strong written and verbal communication skills
Must be organized and able to prioritize duties and responsibilities
Must demonstrate initiative, innovation, and sound analytical problem-solving skills
Must be able to interact with all levels and disciplines of employees
Must have attention to detail and multi-tasking
Deviation investigation and Corrective Action and Preventive Action (CAPA) development Experience